Trial Outcomes & Findings for Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer (NCT NCT00416715)
NCT ID: NCT00416715
Last Updated: 2017-07-11
Results Overview
Count of early breast cancer patients prescribed adjuvant letrozole that are vitamin D deficient and who experience myalgias, arthralgias and/or joint stiffness, assessed at baseline and 1 month after vitamin D repletion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Baseline and 1 month post vitamin D repletion
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
Treatment (Letrozole)
Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.
letrozole: Given PO
calcium carbonate: Given PO
laboratory biomarker analysis: Optional correlative studies
calcium citrate: Given PO
calcium glucarate: Given PO
calcium gluconate: Given PO
cholecalciferol: Given PO
assessment of therapy complications: Ancillary studies
musculoskeletal complications management/prevention: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
85
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Treatment (Letrozole)
Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.
letrozole: Given PO
calcium carbonate: Given PO
laboratory biomarker analysis: Optional correlative studies
calcium citrate: Given PO
calcium glucarate: Given PO
calcium gluconate: Given PO
cholecalciferol: Given PO
assessment of therapy complications: Ancillary studies
musculoskeletal complications management/prevention: Correlative studies
|
|---|---|
|
Overall Study
Not evaluable for joint aches
|
7
|
|
Overall Study
Vitamin D levels not evaluable
|
8
|
Baseline Characteristics
Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Letrozole)
n=100 Participants
Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.
letrozole: Given PO
calcium carbonate: Given PO
laboratory biomarker analysis: Optional correlative studies
calcium citrate: Given PO
calcium glucarate: Given PO
calcium gluconate: Given PO
cholecalciferol: Given PO
assessment of therapy complications: Ancillary studies
musculoskeletal complications management/prevention: Correlative studies
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 month post vitamin D repletionCount of early breast cancer patients prescribed adjuvant letrozole that are vitamin D deficient and who experience myalgias, arthralgias and/or joint stiffness, assessed at baseline and 1 month after vitamin D repletion.
Outcome measures
| Measure |
Baseline
n=85 Participants
All patients that are evaluable for joint aches and vitamin D levels.
|
Post Vitamin D Repletion (1 Month)
n=12 Participants
Patients with vitamin D deficiency who experience myalgias, arthralgias and/or joint stiffness.
|
|---|---|---|
|
Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness
|
12 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and 1 month post vitamin D repletionPopulation: Only considering those patients who were baseline vitamin D deficient and experienced myalgias, arthralgias and/or joint stiffness.
Letrezole serum level concentration in patients that were vitamin D deficient and experienced myalgias, arthralgias and/or joint stiffness.
Outcome measures
| Measure |
Baseline
n=12 Participants
All patients that are evaluable for joint aches and vitamin D levels.
|
Post Vitamin D Repletion (1 Month)
n=12 Participants
Patients with vitamin D deficiency who experience myalgias, arthralgias and/or joint stiffness.
|
|---|---|---|
|
Letrozole Serum Levels Before and After Vitamin D Repletion
|
85 micro-grams/mL
Interval 63.0 to 100.0
|
70 micro-grams/mL
Interval 69.0 to 105.0
|
Adverse Events
Treatment (Letrezole)
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Letrezole)
n=100 participants at risk
Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.
letrozole: Given PO
calcium carbonate: Given PO
laboratory biomarker analysis: Optional correlative studies
calcium citrate: Given PO
calcium glucarate: Given PO
calcium gluconate: Given PO
cholecalciferol: Given PO
assessment of therapy complications: Ancillary studies
musculoskeletal complications management/prevention: Correlative studies
|
|---|---|
|
General disorders
Joint aches
|
27.0%
27/100
|
Additional Information
Dr. Hannah Linden
University of Washington / Seattle Cancer Care Alliance
Phone: 206-288-6989
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place